Safety and Immunogenicity of Rotavirus (Bio Farma) Vaccine in Adults, Children and Neonates (Phase I)

Tahapan Penelitian : Awal
Sponsor:
Mitra Pelaksana:
UGM/RS Sardjito
No Registry
INA-2FRR4L5
Tanggal Input Registry : 13-07-2018

09-04-2018
• To know the safety of Rotavirus vaccine (Bio Farma) within 7 days after each dosing.
• To describe the safety of Rotavirus vaccine following 28 days after each dosing • To evaluate the safety of rotavirus vaccine compare to placebo in neonates group • To evaluate the excretion of rotavirus in stools after each dosing in neonates group. • To assess preliminary information of immunogenicity following immunization.
 
Safety and Immunogenicity of Rotavirus (Bio Farma) Vaccine in Adults, Children and Neonates (Phase I)
Safety and Immunogenicity of Rotavirus (Bio Farma) Vaccine in Adults, Children and Neonates (Phase I)
Observasional
Adult&Children: One dose of Rotavirus Vaccine Neonates: Three doses of Rotavirus Vaccine
100
 

Inclusion Criteria:

Inclusion criteria for Adults 1. Healthy Adults as determined by clinical judgment, including a medical history, physical exam and laboratory results, which confirms the absence of a current or past disease state considered significant by the investigator. 2. Subjects have been informed properly regarding the study and signed the informed consent form 3. Subject will commit to comply with the instructions of the investigator and the schedule of the trial. Inclusion criteria for Children 1. Healthy Children as determined by clinical judgment, including a medical history and physical exam, which confirms the absence of a current or past disease state considered significant by the investigator. 2. Parents/guardian(s) have been informed properly regarding the study and signed the informed consent form 3. Parent/guardian(s) will commit to comply with the instructions of the investigator and the schedule of the trial. Inclusion criteria for Neonates 1. Neonate 0-5 days of age at the time of first dose, with cord blood available 2. Neonate is in good health as determined by clinical judgment, including a medical history and physical exam, which confirms the absence of a current or past disease state considered significant by the investigator. 3. The neonate was born full term (minimum of 37 completed weeks and maximum of 42 completed weeks gestation). 4. Neonate birth weight 2500-4000 g inclusive. 5. Parents or guardians have been informed properly regarding the study and signed the informed consent form 6. Parents or guardians will commit to comply with the instructions of the investigator and the schedule of the trial

Exclusion Criteria:

Exclusion criteria for Adults: 1. Subject concomitantly enrolled or scheduled to be enrolled in another trial 2. Any direct relatives relationship with the study team. 3. Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature ³ 37.5°C) within the 48 hours preceding enrollment. 4. Known history of allergy to any component of the vaccines (based on anamnesis) 5. Known history of immunodeficiency disorder (HIV infection, leukemia, lymphoma, or malignancy) 6. Gastroenteritis in the 24 hours preceding dosing. 7. History of uncontrolled coagulopathy or blood disorders contraindicating for phlebotomy. 8. Subject who has received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products, or corticosteroid therapy and other immunosuppresant). 9. Subject consuming or expect to consume a probiotics within one week before and after dosing 10. Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives. 11. Pregnancy or planning a pregnancy within the next 3 months & lactation (Adults). 12. Subject already immunized with any vaccine within 4 weeks prior and expects to receive other vaccines within 4 weeks following immunization. 13. Subject planning to move from the study area before the end of study period. Exclusion criteria for Children: 1. Subject concomitantly enrolled or scheduled to be enrolled in another trial 2. Any direct relatives relationship with the study team 3. Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature ³ 37.5°C ) within the 48 hours preceding enrollment 4. Known history of allergy to any component of the vaccines (based on anamnesis) 5. Known history of immunodeficiency disorder (HIV infection, leukemia, lymphoma, or malignancy) 6. Gastroenteritis in the 24 hours preceding dosing. 7. Any clinically significant history of chronic gastrointestinal disease including uncorrected congenital malformation of gastrointestinal tract that would predispose for Intusussception. 8. History of uncontrolled coagulopathy or blood disorders contraindicating for phlebotomy. 9. Subject who has received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or corticosteroid therapy and other immunosuppresant). 10. Subjects consuming or expect to consume a probiotics within one week before and after dosing. 11. Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives. 12. Individuals who have previously received any rotavirus vaccine. 13. Subject already immunized with any vaccine within 4 weeks prior and expects to receive other vaccines within 4 weeks following immunization. 14. Subject planning to move from the study area before the end of study period Exclusion criteria for Neonates: 1. Subject concomitantly enrolled or scheduled to be enrolled in another trial. 2. Any direct relatives relationship with the study team. 3. Evolving mild, moderate or severe illness, especially infectious diseases or fever (axillary temperature ³ 37.5°C) within the 48 hours preceding enrollment. 4. Subject with known or suspected history of allergy to any component of the vaccines (based on anamnesis) 5. Subject with a biological mother with a known or suspected human immunodeficiency virus (HIV) infection. 6. Subject with known or suspected major congenital malformations or genetically determined disease. 7. Subject with intussusception. 8. Subject with a known or suspected disease of uncontrolled coagulopathy or blood disorders contraindicating for phlebotomy. 9. Subject with a known or suspected disease of the immune system or those who has received immunosuppresive therapy, including immunosuppresive courses of systemic corticosteroid. 10. Subject who have ever received any blood products, including immunoglobulin, or for whom receipt of any blood product during the course of study. 11. Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives. 12. Subject immunized with non- EPI vaccines. 13. Gastroenteritis in the 24 hours preceding dosing. 14. Subject planning to move from the study area before the end of study period.
 
KE/FK/0086/EC/2018
NA
B-PN.01.06.313.04.18.01367
RV0117
dr. Jarir At Thobari, PhD